TriVascular Technologies, Inc. Announces FDA Approval of Ovation iX(TM) Iliac Stent Graft »
Enhancements to Iliac Stent Graft Technology Are Designed to Improve Ease of Use and Expand Patient Applicability
Santa Rosa, Calif., June 15, 2015 (GLOBE NEWSWIRE) -- TriVascular Technologies, Inc. (Nasdaq:TRIV) announced today that the U.S. Food and Drug Administration (FDA) has approved the Ovation iX Iliac Stent Graft for the Ovation Prime® Abdominal Stent Graft System, together with manufacturing enhancements that will facilitate a broader commercial launch of the product. Building upon the strength of the Ovation® and Ovation Prime iliac technology, the Ovation iX iliac stent graft is engineered to promote patency even in hostile anatomy. Ovation iX stands for integrated exchange, and the iliac stent graft was developed to improve physician ease of use and expand patient applicability. The less invasive, low-profile (10-13F) integrated sheath is designed to minimize vessel trauma. With flared limbs up to 28mm diameter and limb lengths up to 160mm, the broader size matrix and even lower profiles enable treatment of a wider range of AAA anatomies.
"The approval of the Ovation iX limb technology is yet another example of TriVascular's responsiveness to clinical feedback," commented Syed Hussain, MD, Chairman of Vascular and Endovascular Surgery at Christie Clinic and Assistant Professor of Surgery at the University of Illinois. "The integrated sheath will minimize catheter exchanges and vessel trauma. In addition, the expanded size matrix enables me to offer an endovascular repair to a broader population of my patients."
"While lower profile systems have expanded the applicability of EVAR in patients with small or diseased access vessels, concerns of reduced limb patency have surfaced in other low profile grafts, negating much of their potential benefit," explained David Minion, MD, Professor of Surgery and Program Director for Vascular Surgery at the University of Kentucky Medical Center. "In contrast, our experience with the Ovation system, and specifically the Ovation iliac limb technology, is excellent in even the most challenging access cases. The new iX technology solidifies the Ovation system's status as unsurpassed from top to bottom."
"The approval of the Ovation iX iliac stent graft further demonstrates our commitment to product innovation, expanding EVAR access to more patients and improving EVAR for all patients," said Christopher G. Chavez, Chairman, CEO and President of TriVascular. "We are dedicated to rapidly delivering new technology to enable physicians to treat more patients safely and are grateful to the many clinicians worldwide who count on us as a trusted partner in patient care."
The Ovation platform has been used in the successful treatment of approximately 7,000 patients worldwide. Excellent clinical results have been reported from both the Ovation global pivotal trial and a 501-patient European Post-Market Registry. As previously announced, the company had received CE Mark clearance and FDA approval for the Ovation iX iliac stent graft, and submitted supplemental regulatory filings for manufacturing improvements designed to realize efficiencies. This approval enables a broader commercial launch of the Ovation iX iliac stent graft. The Ovation Prime system is available for sale in over 35 countries around the world.
About TriVascular Technologies, Inc.
TriVascular is a medical device company developing and commercializing innovative technologies to significantly advance minimally invasive treatment of abdominal aortic aneurysms. The company manufactures the Ovation Prime Abdominal Stent Graft System, the lowest profile FDA-approved EVAR system, which utilizes a novel, polymer-based sealing mechanism. TriVascular is based in Santa Rosa, California.
In addition to the historical information, this press release contains forward-looking statements with respect to our business, the Ovation system, our stent graft technology and our ability to expand EVAR treatment option to a broader population of patients with AAA disease. These forward-looking statements are based upon information that is currently available to us or our current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including our ability to successfully commercialize our products; continued market acceptance of our endovascular aortic repair systems; our ability to manufacture our endovascular systems to meet demand; the level and availability of third party payor reimbursement for our products, our ability to effectively manage our anticipated growth; our ability to protect our intellectual property rights and proprietary technologies; our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; our ability to develop new or complementary technologies; the regulatory requirements applicable to us and our competitors; competition in our industry; additional capital and credit availability, our ability to attract and retain qualified personnel; product liability claims; and general economic and worldwide business conditions. These factors, together with those that are described in greater detail in our Annual Report on Form 10-K filed with the SEC on March 9, 2015 and our other filings with the SEC, may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. We expressly disclaim any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.